E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Posttraumatic stress disorder |
Posttraumatische stress stoornis |
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E.1.1.1 | Medical condition in easily understood language |
posttraumatic stress disorder |
posttraumatische stress stoornis |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036316 |
E.1.2 | Term | Post-traumatic stress disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the effectiveness of the administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) in reducing PTSD and co-morbid depressive symptoms in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a reduction in PTSD and depressive symptoms over the course of the treatment, but that the reduction in symptoms will be faster and larger in the oxytocin group. |
Primaire vraagstelling van deze studie is om de effectiviteit van oxytocine te onderzoeken in vergelijking met placebo als een toevoeging aan exposure sessies (NET) in de behandeling van PTSS. We veronderstellen dat het toevoegen van oxytocine aan exposure in NET de afname in symptomen van PTSS versnelt en vergroot in vergelijking met placebo. Eveneens wordt verondersteld dat de afname in co-morbide depressieve symptomen sterker zal zijn in de oxytocine groep.
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to investigate whether administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) is more effective in dampening stress reactivity in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a dampening of both self-reported and physiological stress-reactivity (heart rate, heart rate variability, salivary cortisol), but that the dampening of stress reactivity will be faster and larger in the oxytocin group. |
Secundaire vraagstelling is om te onderzoeken of oxytocine toevoeging aan NET bij PTSS leidt tot een sterkere verandering in stress reactiviteit dan wanneer placebo wordt toegevoegd. Verondersteld wordt dat het toevoegen van oxytocine zal leiden tot een sterkere en snellere afname van subjectieve en fysiologische stress reactiviteit dan wanneer placebo wordt toegediend. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with a diagnosis of chronic PTSD (> 3 months) -CAPS score of 50 -Age 18-65 years -Written informed consent |
- Patienten met een diagnose van chronische PTSS (> 3 maanden) -CAPS score 50 -Leeftijd 18-65 jaar -Schriftelijke toestemming |
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E.4 | Principal exclusion criteria |
-Suicidal risk. - Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, or excessive substance related or eating disorder over the past 6 months. - Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month). - Female patients with an active pregnancy wish. - Female patients giving lactation to their child. - Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent). - An organic disorder/cognitive impairment. - Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used. -Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers. -Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat) -Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year. |
-Suicide risico -Aanwezigheid van één van de volgende DSM IV diagnoses, op het moment of in het verleden: psychotische stoornis, incl, schizofrenie, een bipolaire stoornis, of ernstige verslavingsproblematiek of eetstoornis in de afgelopen 6 maanden -Zwangere vrouwen (vrouwelijke patienten in hun vruchtbare levensfase moeten een negatieve zwangerschapstest hebben, deze wordt elke maand herhaald) -Vrouwelijke patienten met een actieve zwangerschapswens - vrouwelijke patienten die borstvoeding geven - diagnose van ernstige depressieve stoornis (met psychotische trekken en/of hoge suicide intentie) -Een organische aandoening of cognitieve beperking - patienten die psychotrope medicatie gebruiken zullen minstens twee maanden voorafgaand aan de voormeting (een stabiele dosis moeten gebruiken. Psychotrope medicatie die al tijdens de voormeting wordt gebruikt zal worden gehandhaafd tot de nameting. Tijdens de studie zal geen psychotrope medicatie worden voorgeschreven tenzij er ernstige depressieve symptomen ontwikkeld worden. Er zal een medicatie protocol gebruikt worden dat overeenkomt met klinische richtlijnen (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005). - Het gebruik van bepaalde medicatie: prostaglandines, bepaalde anti-migraine medicatie (ergot alkaloides), bèta-adrenerge recepterblokkerende middelen en systemische glucocorticoiden; - Overgevoeligheid/allergie voor oxytocine of de bestanddelen (bv methylhydroxybenzoaat en propylhydroxybenzoaat) - Aanwijzingen voor klinisch significante,onstabiele medische toestand, waarbij een contraindicatie bestaat voor toediening van oxytocine, zoals cardiovasculaire, gastro-intestinale, pulmonaire, renale, endocriene of hematologische stoornissen, glaucoom, epilepsie in de anamnese, of een beroerte of myocardinfarct in het afgelopen jaar. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary study endpoints are levels of PTSD and co-morbid depressive symptoms. PTSD symptoms will be assessed by means of clinical diagnostic interviews (Clinician-Administered PTSD Scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and self-report questionnaires (Impact of Events Scale-Revised, measured at all assessment points). Depressive symptoms will be assessed by self-report questionnaire (Beck Depression Inventory, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session). |
Primaire uitkomstmaten zijn de ernst van PTSS en co-morbide depressieve symptomen. PTSS zullen worden gemeten met behulp van een klinisch diagnostisch interview (CAPS, afgenomen op voormeting en nametingen 1-3 en 14-16 weken na laatste NET sessie) en vragenlijst (IES-R, afgenomen op alle meetmomenten). Depressieve symptomen zullen worden gemeten met behulp van een vragenlijst (BDI, afgenomen op voormeting en nametingen 1-3 en 14-16 weken na laatste NET sessie). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After each NET session, and 1-3 and 14-16 weeks after the final NET session |
Na elke NET sessie, en 1-3 en 14-16 weken na de laatste sessie |
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E.5.2 | Secondary end point(s) |
Secondary study endpoints are measures of stress-reactivity, both self-reported (Perceived Stress Reactivity scale, assessed before the first session and at 1-3 and 14-6 weeks after the final NET session) and physiological stress reactivity (heart rate, heart rate variability and salivary cortisol, assessed after each NET session). |
Secundaire uitkomstmaten zijn maten van stress-reactiviteit, zowel zelf-gerapporteerde (PSRS, gemeten op voormeting en nameting 1-3 en 14-16 weken na laatste NET sessie) als fysiologische stressreactiviteit (hartslag, hartslag variabiliteit, speeksel cortisol, gemeten na afloop van elke NET sessie). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After each NET session, and at 1-3 and 14-16 weeks after the final NET session |
Na elke NET sessie, en 1-3 en 14-16 weken na de laatste NET sessie |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |